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QuidelOrtho Nabs CLIA Waiver for COVID-19 Antigen Test

NEW YORK — QuidelOrtho said on Thursday that it has received a CLIA waiver from the US Food and Drug Administration for the Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay for COVID-19 antigen detection.

The prescription use-only test runs on the Sofia 2 fluorescent immunoassay analyzer and is intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens. Results are provided in about 10 minutes, QuidelOrtho said.

Both the assay and the analyzer received de novo authorization from the FDA in March. With the CLIA waiver, the test is now cleared for use in point-of-care settings without the need for trained laboratory personnel. Quidel, which merged with Ortho Clinical Diagnostics in mid-2022, was granted Emergency Use Authorization from the FDA for a previous version of the test in June 2020.